Status:
RECRUITING
Glucagon-Like Peptide-1 Receptor Agonist in ADPKD
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Washington University School of Medicine
Mayo Clinic
Conditions:
Autosomal Dominant Polycystic Kidney
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The proposed clinical trial aims to assess if a year of treatment with a glucagon-like peptide 1 receptor agonist, a medication approved for weight management that also improves the body's response to...
Detailed Description
Autosomal dominant polycystic kidney disease (ADPKD) is a common inherited disorder that leads to kidney failure. The only approved treatment to decelerate kidney disease progression in patients with ...
Eligibility Criteria
Inclusion
- 18-65 years of age
- ADPKD diagnosis based on the modified Pei-Ravine criteria
- Body-mass index of ≥27 kg/m\^2
- Estimated glomerular filtration rate ≥ 30 mL/min/1.73m\^2
- Mayo Classification of C, D, or E, calculated from a previous kidney ultrasound or MRI performed within the last 12 months
- Not currently participating in or planning to participate in any formal weight loss or physical activity program, or another interventional study
- Ability to provide informed consent
Exclusion
- Diabetes mellitus
- Tolvaptan usage or plans to initiate tolvaptan
- History of hospitalization or major surgery within the last 3 months
- Uncontrolled hypertension (systolic blood pressure \> 160 or diastolic blood pressure \>100 mm Hg)
- Pregnancy, lactation, or unwillingness to use adequate birth control
- Regular use of prescription or over-the-counter medications that may affect weight, appetite, food intake, or energy metabolism
- History of clinically diagnosed eating disorder including: anorexia nervosa, bulimia, binge eating disorder
- Weight change of \>5% in the past 3 months for any reason except post-partum weight loss
- Inability to cooperate with or clinical contraindication for MRI including: severe claustrophobia, implants, devices, or non-removable body piercings
- Presence or personal history of malignant neoplasm within 5 years prior to the day of screening
- Personal or family history of medullary thyroid carcinoma, thyroid nodule, or multiple endocrine neoplasia type 2
- Prior history of pancreatitis
- Weight ≥450 lb
Key Trial Info
Start Date :
March 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2029
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT06582875
Start Date
March 6 2025
End Date
June 30 2029
Last Update
May 6 2025
Active Locations (1)
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1
University of Colorado - Anschutz Medical Campus
Aurora, Colorado, United States, 80045